FDA approves Celltrion's Avtozma, a biosimilar to Actemra
The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South Korean firm Celltrion (Kosdaq: 068270).
Avtozma is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).
Marketed by Swiss pharma giant Roche (ROG: SIX), Actemra generated full-year 2024 sales of 1,331 million francs ($1,358 million) in the USA, up 11% on the previous year, for the company.
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